This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in patients ages 10 to 16 years old with ADHD and comorbid dyslexia

To evaluate maintenance of benefit after discontinuation of treatment with atomoxetine in patients who were previously assigned to atomoxetine during the acute treatment period. These patients will be re-randomized to atomoxetine or placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Atomoxetine will be administered at 1.0 to 1.4 mg/Kg/day given orally once daily in the morning for 16 weeks (study period II). Patients who complete the study period II will be re-randomized in the study period III of 16-week duration to assess maintenance of benefit following discontinuation of treatment with atomoxetine. Patients assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas patients previously assigned to placebo will receive atomoxetine.

Drug: Atomoxetine

Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 32 weeks

Other Name: LY139603

Placebo Comparator: 2

Placebo will be packaged in the same way as active comparator will to enforce double-blind study design

Drug: Placebo

oral, daily, for 32 weeks

Detailed Description:

This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in patients with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of patients with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects & effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.

Eligibility

Ages Eligible for Study:

10 Years to 16 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must meet DSM-IV-TR criteria for ADHD

Patient must meet DSM-IV-TR criteria for dyslexia

Patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient

Child or adolescent patients must be 10 to 16 years old

Must be able to communicate in English

Must be able to swallow capsules

Be reliable to keep appointments for clinic visits & all related tests

Subjects for healthy control group do not meet DSM-IV-TR criteria for AHHD and/or dyslexia

Subjects for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient

Exclusion Criteria:

Patients who weigh less than 25 kg or greater than 70 kg

Patients with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions

Patients with prior diagnosis of bipolar I or bipolar II disorder or psychosis

Patients with documented history of autism, Asperger's syndrome, or pervasive developmental disorder

Females who are pregnant or breastfeeding

Patients treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716274

Contacts

Contact: There is only one site for this clinical trial 1-877-CTLILLY (1-877-285-4559) or